Organization: Center for HealthCare Improvement, Anne Arundel Medical Center, Annapolis MD.

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1 Organization: Center for HealthCare Improvement, Anne Arundel Medical Center, Annapolis MD. Solution Title: Sustained Reduction of Narcotic Induced Over-Sedation and Respiratory Depression: A Multi-focal Patient Safety Enhancement. Program/Project Description Introduction and Background: Patient harm due to narcotic induced Over-Sedation and Respiratory Depression (OS-RD) in hospitals is a nationwide problem. It is estimated that 51% of hospitalized patients receive narcotics, often at high doses; nearly a quarter receiving > 100 mg/day of oral morphine equivalents. 1 Of these patients, % of experience serious adverse effects. 1-3 Common underlying contributing factors are failure to monitor adequately, and errors of dosing found in 60% and 47% of events, respectively. 3 Many patient-level risk factors have been identified including the common conditions of obesity, sleep apnea, heart failure, advanced age and the concurrent use of other sedating medications, 3 all of which are common among hospitalized patients. Narcotic safety is further compromised by the considerable overlap between safe and unsafe doses between individual patients. Further, the multiple different types and forms of narcotics and the need to convert from one to another create the opportunity for harm due to prescribing errors. The AAMC Harms Review Committee became aware of an increase in narcotic induced (OS-RD) evens by utilizing the Institute for Healthcare Improvement s (IHI) screening Global Trigger tool (GTT) and data collected through AAMC s voluntary incident reporting system. Baseline data was obtained from the Pharmacy and Therapeutics Committee (P&T) which measured naloxone use via pharmacy reporting. Based upon these data it was determined that the problem was a serious one with diffuse causes and would require a multifocal quality and safety initiative across the entire organization to successfully address the existing issues. Goal: The goal of this project was the elimination of narcotic induced over-sedation and respiratory depression throughout the hospital. With leadership support, a variety of educational and electronic medical record (EMR) based tools were used. The success of the program was evaluated by monitoring the use of naloxone, a specific reversal agent used for narcotic OS-RD. However, because naloxone use maybe non-specific, potentially used for other causes of altered mental status or respiratory depression, detailed review of medical records of all patients receiving naloxone was required

2 Process: In June 211 AAMC adopted the Institute of Healthcare Improvement (IHI) Global Trigger Tool (GTT) in order to improve the process of identifying harm within the organization. The GTT focuses on system processes involving general care, surgical, medication, emergency department, intensive care, and perinatal by identifying triggers in the record that identifies harm. All harm events identified through the bi-weekly GTT review, along with events identified through AAMC s incident reporting system and preventable death review, are evaluated monthly by the Harms Review Committee. The Harms Review Committee, an interprofessional team colead by the Chair of Quality Improvement and the Director of Nursing Quality and Research, consists of representatives from nursing, medical staff, hospital pharmacy, data analytics and risk management. Its mission is to review the triggers of harms and seek opportunities for systemwide process improvement. In September 2012, the Harms Review Committee identified an apparent spike in narcotic induced OS-RD as measured both by use of naloxone as a reversal agent and calls to the incident reporting system. Individual chart review verified as cases of narcotic induced OS-RD. Consequently, in October 2012, the Harms Review Committee retrospectively reviewed in depth all inpatient naloxone events from July 1, 2011 through July 31, 2012, excluding patients who came to the ED with narcotic overdose. Thirty-three episodes of confirmed narcotic induced OS-RD events were identified, 1/3 of which occurred on the joint and spine. Based upon this review, the P&T Committee, formed an interprofessional Sedation Task Force (STF). The STF was tasked to identify causes, review the medical literature for solutions and create an action plan and implementation strategies to eliminate OS-RD due to narcotics. Numerous areas of concern were identified; some described elsewhere in the medical literature and others a result of hospital level factors. A description of the issues and the solutions adapted is provided below. Solution: Analysis of our own data and review of the literature suggested that there were many different steps in the care process in which errors lead to narcotic induced OSA-RD. As well, there were deficits in knowledge about principles of narcotic use that manifest in repeated types of errors. These common paths to RS-OD are categorized in the tables below.

3 Table 1. Risk Factors for Over-Sedation and Respiratory Depression PATIENT CHARACTERISTICS THAT INCREASE RISK Age >60 Concomitant use of other CNS depressants BMI >30 Opioid naïve Cr. Cl. < 30 ml/min Co-morbid conditions: Sleep apnea (or history of snoring) symptomatic CHF or COPD, TYPES OF DOSING ERRORS Incorrect conversions among different Too rapid dose escalation narcotics and among oral, IV and transdermal forms Pre-op use of long acting narcotics Long acting narcotics in narcotic-naïve patient Combining narcotics OTHER INSTITUTIONAL PRACTICES Failure to appreciate link between sedation Inadequate monitoring of patients and respiratory depression Transferring highly sedated patients from PACU to floors. Transfer of patients from PACU to floor immediately after repeat narcotic dosing Table 2 shows the categories of deficiency and the solutions introduced Table 2. Solutions adapted by category of deficiency Categories of Deficiencies Inadequate sedation monitoring Inconsistent sedation assessments of patients receiving narcotics: -Different scales in use -No uniform practice on frequency of assessment or action steps to be taken. Outdated Ramsey assessment tool not appropriate for assessing sedation related to pain management and lacked recommended interventions. Solutions introduced Medical literature reviewed to identify evidence-based sedation assessment scales for goal directed sedation, postop recovery, opioid pain management, etc. -Tool should have recommended intervention steps after assessment. -Identified the Pasero Opioid sedation Score in peer reviewed literature. -Feasibility trial for the POSS trial conducted on the Joint and Spine unit since it had a high incidence of oversedation events. -Implement the Pasero Opioid Sedation Scale (POSS) with corresponding interventions as the standard evidencebased tool for sedation assessment at AAMC.

4 Hospital policies did not adequately address the optimum scale or the frequency monitoring to be done. Cultural Determinants Poor communication among team members regarding level of sedation. The clinical culture stressed the elimination of pain and/or the achievement of a pain score below an arbitrary number. Educational and Practice Deficits Administered an Opioid Knowledge Assessment to inpatient healthcare providers (hospitalists) and pharmacists to identify gaps in knowledge about narcotics. Knowledge deficits identified in the following areas: - Narcotic conversions - Patient-level risk factors: age, and co-morbid conditions (obesity, sleep apnea risk, heart failure COPD - other sedating medications -risk of long acting medications -definition of narcotic-naïve -danger of rapid escalation -cross tolerance -Provide education to all nursing staff members in multiple formats including educational video via Healthstream- -Sedation documentation build linked to a nursing documentation flow sheet that includes pain score and vital signs. Tested in EMR playground and revised as needed. Re-tested in Joint and Spine unit and then introduced across institution. - Hospital policies on pain management revised to include use of POSS tool and standardize frequency of assessment. -Implemented a new report within the EMR to show pain scores, POSS sedation score, medication given and vital signs in a single location. -Introduced discussion of sedation score to the content of daily morning interprofessional rounds. -Re-educated staff that goals of pain management should be individualized. -Hospital policies on pain management revised to reflect a better understanding of this concept. -Education delivered to hospitalists by Pain Management Specialist Nurse Practitioner tailored to deficits identified by Opioid Knowledge Assessment. -Create, within the EMR, a live link to a narcotic conversion table created by IT after approval by P&T committee. - Naloxone algorithm linked to the MAR for easy reference whenever a narcotic is used. - Created Clinical Decision Support Best Practice Alert to fire when initiating narcotics in patients with comorbid conditions and/or other sedating medications. Advisory recommends lower starting doses and close monitoring. - Computerized Decision Support default to a lower dose narcotic drip for

5 High incidence of OS-RD with hydromorphone (used frequently in ED and then converted to drips on the floors). Problematic because less familiarity with hydropmorhone and doses used were too high. Lack of appreciation for sedation as the antecedent to respiratory depression. Risks of long acting opioids in opioid-naïve pts Misunderstanding of the definition of narcotic naïve high risk patients based upon computer detection of patient factors identified in the chart: problem list, BMI, age, renal insufficiency. -Reduced ED hydromorphone use by creating new pain order sets with default to morphine. -Added morphine 4 mg to Pyxis instead of hydromorphone. -Discussion of sedation levels during interprofessional morning rounds. - Emphasis on use of POSS score which has recommendations for physicians and nurses. --Removal of long acting narcotics from pre-op orthopedic order set. -Best practice alert when ordering long acting narcotics that defines narcotic naïve to ensure that long acting narcotics are not added prescribed inappropriately. Examples of some of the enhanced tools are shown below. Exhibit 1. Pasero Opioid Sedation Scale (POSS) introduced into clinical practice POSS Score Action 1 = Awake and alert Acceptable; no action necessary; may increase opioid dose if needed, contact prescribing physician if an order to increase dose is needed. 2 = Slightly drowsy, easily Acceptable; no action necessary; may increase opioid dose aroused if needed, contact prescribing physician if an order to increase dose is 3 = Frequently drowsy, but arousable, drifts off to sleep during conversation needed. Unacceptable Obtain VS, O2 sat, enter respiratory consult to assess end tidal CO2 Hold additional pain medication and contact provider for recommendation Increase frequency of monitoring to every 15 minutes x4, every 30 minutes x 2, every 1 hour x1 4 = Somnolent, minimal or no response to verbal or physical stimulation Unacceptable Stop narcotic infusion or PCA do not administer any additional narcotics or sedatives

6 Call Rapid Response Team Contact provider for recommendation Consider administration of naloxone see AAMC Naloxone algorithm o Obtain VS, O2 Sat, blood glucose, and end=tidal CO2 via Respiratory Therapist o Consider labs glucose, sodium, and H&H o Consider transfer to Critical Care Exhibit 2. Cover Page for Sedation Scale Educational Tool

7 Exhibit 3. Integrated Documentation Flow Sheet Showing Inclusion of Pain Score, Vital Signs and Sedation Level. Corresponding Interventions are Shown to the Right of the Field for Easy Reference. Measurable Outcomes: The primary goal of this quality improvement project was to eliminate narcotic induced OS-RD. Because deaths are rare, we relied upon a surrogate marker to use as an indicator of clinical over- sedation or respiratory depression. Naloxone administration is a useful proxy as it is administered for OS-RD and is easily tracked by pharmacy data bases. Naloxone use can be nonspecific though, therefore all instances of its use need to be reviewed by experienced clinicians to verify that the patient actually had narcotic induced OS-RD. Excluded from this analysis are instances of narcotic over-sedation and respiratory depression that occur as outpatients and who receive naloxone in the emergency department.

8 We found an association between use of pre-operative, long acting opioids in orthopedic surgery patients in which these medications was built into order sets, even though this is recognized as a dangerous practice. Figure 1 shows the frequency of naloxone use over time as the protective measures were introduced. The incidence has fallen for 5 consecutive quarters indicating the results are not due to random statistical variation. Figure 1. Frequency of Naloxone Utilization in Verified Cases of Narcotic Induced Over Sedation or Respiratory Depression Figure 2 indicates that the performance improvement steps did not have a significant adverse impact on patient satisfaction with pain management. We continue to monitor patient satisfaction with regard to pain management.

9 % of Always Responses Figure 2. Patient Satisfaction with Pain Management. Hospital-Level aggregate scores. (HCAHPS) Sustainability: 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Aggregate Pain Management Satisfaction Scores Oct - Dec 2012 Jan - Mar 2013 Apr - Jun 2013 Jul - Sept 2013 Oct - Dec 2013 Jan - Mar 2014 Apr - Jun 2014 Overall IP 79% 80% 78% 78% 77% 81% 76% Overall IP Benchmark 74% 74% 74% 74% 74% 74% 74% The evidence for sustained improvement can be seen from the extended number of data points indicating a reduction in events, thus meeting most definitions of sustainability. In order to sustain improvements, many enhancements have been built into to the care delivery system, the electronic record system (Epic, Aurora WI) or workflows including: -Renewed emphasis on Goals of analgesia discussions rather than reduction of pain score below a certain arbitrary number on a Likert scale consistent with new recommendation by TJC. -Requirement for sedation monitoring prior to and one hour after each narcotic dose -Display of pain scores with narcotic doses in an easily visible accordion document. -sedation level discussed on multi-disciplinary morning rounds and with handoffs. -POSS Scale Included in SBAR Nursing Bedside Shift Report -Monthly unit by unit random audit of compliance with the sedation monitoring tool (POSS) opioid administration and one hour following. In addition, we have introduced: -Mandatory annual POSS education for all nurses -New nursing employees receive classroom education on pain management and POSS administration based upon the new policy -One hundred percent case review of naloxone use in verified narcotic induced OS-RD, is performed bi-monthly by the multi-disciplinary Global Trigger Tool team and trended in Harms Review Committee

10 Exhibit 4. SBAR for nursing handoffs including POSS score

11 Exhibits 5. Computer Home Screen Reminder to be Aware of POSS, Indicating Cultural Emphasis at AAMC on the Issue of Narcotic Safety. Role of Collaboration and Leadership: Because narcotic over-sedation and respiratory depression can occur at many steps in the care pathway, pharmacists, nurses and physicians each have important roles to play in reducing harm. Our critical reading of the medical literature and analysis of our own baseline and new cases indicated many areas of care which needed improvement. This required the involvement of numerous disciplines and committees within the hospital; work that was coordinated by the Center for Healthcare Improvement, a coordinating center to drive safer processes and workflows. Different skill sets and clinical backgrounds were needed for the following tasks: -Literature review for discussions of contributing causes from other published reports. -Research for evidence based practice sedation assessment tools. -Analytic chart review -Development of educational materials, roll-out of educational programs house wide. -Electronic medical record build with new order sets, narcotic conversion table and flow sheets -Revision of policies, -Approval of nursing practice changes. -Implementation of pilot testing. -Education of staff in multiple formats. Partners and Participants Involved:

12 Multiple partners and participants across the organizations worked collaboratively to ensure successful strategies were implemented to eliminate over-sedation. Below are the key committee and committee leads involved. Listed below are highlights of the role of various councils, committees, task forces and team across the organization that partnered to reduce over-sedation and respiratory depression. Center for Health Care Improvement Board of Trustee Quality Safety Committee Executive Quality Council Global Trigger Tool Team and Quality Department (Harm Team). Harms Review Committee Pharmacy and Therapeutics Committee Sedation Task Force Joint and Spine Unit Nursing Clinical Education Committee Information Systems Coordinating role for tracking the different initiatives and analyzing data. Committee including community leaders and patient advocates established the reduction of patient harm as an organizational strategic aim. Asserted governance of the narcotic safety project and received regular reports on implementation and outcomes. Clinical and administrative leaders along with patient advocates approved and monitored implementation and outcomes. Evaluated and monitor all naloxone usage events in the medical center Measured the magnitude of the problem, identified over-sedation as significant risk factor for respiratory depression. Made initial recommendation for solutions. Developed a multi-disciplinary Sedation Task Force specifically to reduce over-sedation. Approved narcotic conversion table appended to orders. Approved lower dose narcotic drips for high risk patients. Fostered the conversion form dilaudid therapy in the Emergency department and subsequent dilaudid drips to morphine. Identified factors related to over-sedation at AAMC and adopted the POSS Scale Piloted the POSS Scale Nursing Clinical Education Committee developed an educational plan for all nursing staff. Re-oriented nursing teams toward realistic and achievable pain goals rather than elimination of pain as the goal Electronic medical record build for POSS documentation. Accordion file built to increase view ability of pain scores and narcotic doses. Electronic medical record build for Best Practice Advisories, change in order sets including reduced dose narcotic drips, promotion of morphine over hydromorphone by default order, linkage of narcotic conversion table to the narcotic order.

13 Organizational Leadership Engagement and Shared Vision for Success The reduction of over-sedation events at AAMC involved leadership engagement. The executive leadership made reduction of narcotic induced over-sedation and respiratory depression an organization priority promoting the initiative at the many different committees with responsibility for patient safety. Progress on both implementation of safety measures and overall results was monitored at the high level committees. The Center for Health Care Improvement, a leadership coordinating body lead by a medical staff, Chair, took responsibility for researching the problem, collecting and analyzing internal data and formulating solutions that were vetted by numerous other committees and work groups. All levels of leadership had a shared vision and goal to reduce patient harm by eliminating over-sedation events. The successful development and implementation of this plan involved all levels of the organizational quality structure - Board of Trustees, Board Quality and Patient Safety Committee, Executive Quality Council, Medical Executive Committee, Nursing Quality Council, Medicine Services Quality Council, Surgical Services Quality Council, Maternal Child Health Quality Council, Center for Healthcare Improvement, Quality and Patient Safety Department, Department Leaders, and healthcare staff. Board of Trustees Quality and Safety Committee Maulik Joshi Dr. P.H., MHSA Ken Gummerson M.D. Sherry Perkins Ph.D., R.N. Shirley Knelly M.S. CPHQ Co- Leaders of Harms Review Committee Barry Meisenberg, MD Cathaleen Ley, Ph.D., RN Global Trigger Tool Review Team Jane Rhule, RN John Ness, PharmD Elaine Arata, MD Sedation Task Force Barry Meisenberg, MD Co-Chair, Board of Trustees Quality and Safety Committee. Community Member President of Medical Staff, Co-Chair of the Board of Trustees Quality and Safety Committee Chief Operating Officer, Chief Nursing Officer, Vice President for Quality and Safety Chair of Quality Improvement and Healthcare System Research. Director for Center for Health Care Improvement Director Nursing Quality and Research Performance Improvement Outcomes Data Analyst Clinical Manager, Inpatient Pharmacy Community Health Care Provider Chair of Quality Improvement and Healthcare System Research

14 Sandy Fox, MSN, RN John Ness, PharmD Jeanette Quigley, MS, CRNP Dave Mooradian M.D. Interdisciplinary Informatics Council Sumati Rao, PhD, RPh Jared Calish, PharmD Lynn Traber, BSN, RN Ray Coluzzi POSS Education Task Force Denise Matteson, BSN, RN Kathy Gowin, BSN, RN Rosanne Proctor, RN Robin Colchagoff, MSN, RN Ann Marie Pessagno, MSA, BSN, RN Vivian Craft, BSN, RN Clinical Nursing Director, Critical Care Manager, Pharmacy Nurse Practitioner, Inpatient Pain Service Chief Medical Informatics Officer Medication Safety Officer Pharmacist System Senior Analyst Information Systems Medical Liaison Clinical Educator, ESP Pre-op/PACU Clinical Educator, Emergency Department Clinical Educator, PACU Clinical Educator, Labor and Delivery Senior Nursing Director of Acute and Critical Care Services Clinical Educator, Critical Care Demonstration of Leadership Support Executive leadership has made reduction in harm an organization-wide strategic aim. Their support for reduction of harm and specifically for elimination of over-sedation events at AAMC is demonstrated by the following: Put resources into the training and implementation of the GTT. Ongoing investment of resources is evident in the ongoing work of of the Harms reduction team. Approve and provide resources for electronic medical record build for POSS and numerous changes in order sets Provide and compensate nurses for annual mandatory POSS training through Skills Day and through a HealthStream module Provide data analytics resource to monitor and measure process measures (compliance with POSS assessment) and outcome measures (naloxone events related to oversedation). Put resources into the training to use the GTT. Ongoing investment of resources is evident in the ongoing work of the Harms reduction team. Innovation: Evidence of innovation can be demonstrated in the use of the EMR (Epic, Aurora WI) to facilitate the changes in both medical and nursing practices that were required. Though the tools built were specific to AAMC s demonstrated needs and existing EMR, they are similar

15 to the needs and tools of all health systems. They are easily adaptable to other institutions. Electronic tools such as Best Practice Advisories to identify patients at risk and suggest safer narcotic conversions, Clinical Decision Support to prompt safer narcotic dosing were introduced to compensate for opioid knowledge deficits even as educational efforts were undertaken. These EMR based solutions then became education tools in their own right, reinforcing more conventional educational efforts. Exhibits 3 and 4 in particular show how practice change was fostered by changes to the work process that were embedded into the EMR. By embedding discussion of sedation status into the nurse hand off process, awareness of sedation as a risk factor became institutionalized. Another innovative aspect was the video education tool developed to facilitate adoption of the sedation scale implemented through Healthstream Innovative thinking is also demonstrated by what we did NOT do. While aware of some studies recommending expanding the use of existing monitoring technology such as oximetry 4 or CO2 monitoring, 5 we performed a critical reading of the medical literature that advocates these capital and labor intensive technologies. Our conclusions were there was insufficient data to recommend these measures. 6 Further we were concerned that increased reliance on electronic alarms could increase auditory disruption for both patients and nurses, increased risk of alarm fatigue generally and create a sense of complacency that reduces vigilance when automated alarms are in place. Our solutions, though tailored to our own demonstrated deficiencies, are nevertheless exportable as they are easy to duplicate or adopt for different electronic medical systems. Related Tools and Resources Tool Global Trigger Tool Implementation Tool Kit Pasero Opioid Sedation Scale (POSS) Opioid Knowledge Assessment Reference ifyingaes.aspx Pasero Chris. Assessment of Sedation During Opioid Administration for Pain Management. Journal of PeriAnesthesia Nursing. 24(3): , June 2009 Grissinger M. Results of the Opioid Knowledge Assessment from the PA Hospital Engagement Network Adverse Drug Event Collaboration. Pennsylvania Patient Safety Advisory 10(1):

16 REFERNCES 1. Herzig SJ, Rothberg, MB, Cheung M, Ngo LH, and Marcantonio ER. Opioid Utilization and Opioid-Related Adverse Events in Nonsurgical Patients in US Hospitals. Journal of Hospital Medicine 2014;9: Jarzyna D, Jungquist CR, Pasero C et al: American Society for Pain Management Nursing Guidelines on Monitoring for Opioid-Induced Sedation and Respiratory Depression. Pain Management Nursing, 12 (3), No 3: , The Joint Commission. Sentinel Event Alert-Safe Use of Opioids in Hospitals Issue 49:1-5 August 8, Taenzer AH, Pyke JB, McGrath SP and. Blike GT. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers 5. Kodali BS. Capnography Outside of the Operating Room. Anesthesiology 118(1): , Ochroch EA, Russell MW, Hanson III WC et al. The Impact of Continuous Pulse Oximetry Monitoring on Intensive Care Unit Admissions form a Postsurgical Care Floor. Anesth Analg.102: , Contact Person: Barry Meisenberg M.D. on behalf of the Sedation Task Force Title: Director, Center for Health Care Improvement, Chair for Quality and Health Systems Research, Anne Arundel Medical Center Meisenberg@AAHS.org

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